Nitazoxanide stabilizing hypsochromic shift based method for its determination in bulk and in pharmaceutical formulation

Nitazoxanide used as antiprotozal agent. There is no method for determination of the drug content in dosage form without drug was acid stabilized and Hypsochromic shift based method. Simple, fast, reliable and Hypsochromic shift based spectrophotometric method has been developed for determination of nitazoxanide in bulk and tablet dosage forms. The quantitative determination of drug was carried out using the zero order values (absorbance) measured at 343.5 nm in 20% v/v 0.1M Citric acid solutions in Methanol. Use of citric acid in solvent system shift the maximum absorbance wavelength to lower side (Hypsochromic shift) and drug was stable in the solvent system (acid stabilized drug). Drug content was determined in within the desirable confidence interval of 98-102%. The proposed method is economic, sensitive, accurate, reproducible and useful for the determination of nitazoxanide in bulk drug and tablet formulations. The method was validated as per ICH guidelines. The proposed method is economic, accurate, reproducible and useful for the determination of nitazoxanide in bulk drug, tablet formulations,biological fluids, dissolution studies, bio-equivalence studies as well as routine analysis in pharmaceutical industries.